In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
This study is prospective cohort study. The study population consists of two different cohorts: 1)
Continued Access Study of the GORE HELEX Septal Occluder and 2) Post-Approval Study of the GORE HELEX Septal Occluder (CA-PAS Subjects HLX 06-04).
Study Population Description
The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter
closure of ostium secundum atrial septal defects. This study will enroll approximately 200 subjects, including subjects from the Icontinued Access Study, who have been successfully implanted.
200 patients, 19 sites
Composite Clinical Success is evaluated at 12 months and is defined as a subject with
the targeted defect assessed by TTE as being either completely occluded or the residual shunt is clinically insignificant, with an absence of repeat procedure to the target ASD, and absence of any major complication.
Followup Visits and Length of Followup
The safety endpoints defined above will be evaluated annually through 5 years post procedure. The
efficacy endpoints defined above will be evaluated at year 1, 3, and 5 post-procedure.During Year 2 and Year 4 of long-term follow-up, the site will contact the subject (or legal guardian if subject is a minor) by telephone to evaluate their status. During Year 3 and Year 5 of long-term follow-up, the site will schedule subject for a follow-up visit. Follow-up visit will include physical examination, ECG, and echocardiogram. A fluoroscopy exam without contrast will be conducted at Year 5.